BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3904159 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10607
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    August 23, 2013
    Report Date
    July 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WILL BE REQUESTED FROM THE FIELD. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE RV LEAD WAS SURGICALLY ABANDONED AND NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS OVERSENSED NOISE NOTED INVOLVING THIS PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO VENTRICULAR PAUSES CAUSED BY PACING INHIBITION DUE TO THE OVERSENSING. THE DEVICE WAS ALSO FOUND TO BE AT END OF LIFE (EOL) BUT THERE ARE NO ALLEGATIONS AGAINST THE BATTERY PERFORMANCE. THE PHYSICIAN ELECTED TO DO A COMMANDED SHOCK TO TEST THE SYSTEM, WHICH WAS SUCCESSFUL AND YIELDED A NORMAL SHOCK IMPEDANCE. DURING THE CHANGE OUT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY UNTIGHTENING THE SETSCREWS IN THE HEADER AND DAMAGE WAS SEEN TO HAVE OCCURRED AROUND THE IS1 CONNECTOR ON THE RV LEAD AS FORCE WAS APPLIED TO REMOVE THE LEAD. THE PHYSICIAN ELECTED TO REPLACE THE WHOLE SYSTEM AND THE RV LEAD WAS SURGICALLY ABANDONED, WHILE THE DEVICE WAS SUCCESSFULLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382950 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR 1871| 0155